EU Clinical Trials Regulation

Credit: Bobby Hidy Flickr, https://goo.gl/I7Op07

The new EU Clinical Trials Regulation, which came into effect in June 2014, contains law that says clinical trials in Europe must be registered and reported — a huge achievement for the AllTrials campaign, run by Sense about Science.

MEPs voted by a huge majority to adopt the Clinical Trials Regulation, 547 in favour and 17 against. This was fantastic news for the campaign; it means that researchers will in future know about trials as they are happening and will be able to scrutinize results soon after their end. This major step forward is due to the efforts of people all over Europe, including many patients who took part in clinical trials, who have pressed their MEPs to set the future straight in this way.

The new Clinical Trials Regulation says that information from Clinical Study Reports of trials should not generally be considered commercially confidential and will:

• Require that all drug trials in Europe are registered before they begin on the publicly accessible EU clinical trials register.

• Require that a summary of the results from these trials is published on the register within a year of the trial’s end.

• Require that a summary understandable to a lay person of what was found in the trial is published on the register.

• Require Clinical Study Reports (detailed documents normally produced for regulatory processes) to be made publicly available, where they are produced.

• Establish a new publicly accessible EU clinical trials register, to be set up and run by the European Medicines Agency.

• Require that all trials used in support of an application to run a new clinical trial are registered or have published results.

• Impose financial penalties on anyone running a clinical trial who does not adhere to these new laws.

Comments

“The new legislation is good news for patients in the future. But as a patient now, I know that I am being given treatments and medicines based on research that has not been made public. I hope that all funders and sponsors of research will publish the results of their research over the past 20 years, so that we can evaluate it in the same way that we will evaluate the research of the future. As a trial participant myself, I would ask everyone who has joined a trial anywhere in Europe to ask when and where the results will be made openly available, and I would ask every European ethics committee to make sure that open and accessible publication of results is made a requirement before researchers are allowed to conduct experiments on patients.” — Richard Stephens, patient and clinical trial participant

“The success of the EU clinical trials regulation vote is one step towards guaranteeing novel treatments are based on all of the available evidence. The regulation, passed today, ensures that new trials are registered, and their results will be published in a timely manner. For patients, this means future treatments are likely to be effective and safe. However, there is a need to carry on with the campaign, in that, clinical trials done on medicines in current practice pre-date this regulation; and much of the evidence base for these treatments is simply missing or incomplete, which is unacceptable.” — Professor Carl Heneghan, director, Centre for Evidence-based Medicine, Oxford

“Having methods and results of all drug trials in the public domain is a big advance and discussions have already started about the practicalities, upsides, and what some may see as potential downsides of sharing this information. It’s time for medical educators, investigators, funders, sponsors, ethics committees, and most importantly – trial participants – to prepare for an era of much greater openness.” — Dr Trish Groves, Deputy-Editor BMJ